Thoratec LLC: CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016; CentriMag RVAD HDE KIT, REF: 104318; CentriMag Pre-connected Pack, REF: CMAEK00; CentriMag VAD KIT, REF: 201-51006, 201-51007, 201-90001 201-90001T; Blood Pump with CentriMag Acute Circulatory Support System for ECMO, REF: CMAEK01. CentriMag Blood Pump is a component to be used with CentriMag Acute Circulatory Support System

Recall number

Z-1099-2026

Recalling firm

Thoratec LLC

Product

CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016; CentriMag RVAD HDE KIT, REF: 104318; CentriMag Pre-connected Pack, REF: CMAEK00; CentriMag VAD KIT, REF: 201-51006, 201-51007, 201-90001 201-90001T; Blood Pump with CentriMag Acute Circulatory Support System for ECMO, REF: CMAEK01. CentriMag Blood Pump is a component to be used with CentriMag Acute Circulatory Support System

Status

Open, Classified

Initiated

2025-10-10

Posted

2026-01-15

Terminated

not on file

Reason

Acute circulatory support system pump may not fit into the motor and reports received of the pump not being securely locked into the motor using the screw-in locking feature. Failure to properly lock the pump into motor my not cause pump not inserted alarm, and could lead to particulate, increased heat, anxiety, inconvenience, delay in hemodynamic/ECMO support, stroke, embolism, death.

Root cause

Process design

Action

In December 2024 Abbott sent a Product Information Letter to reinforce existing IFU. On 10/10/2025, correction notices were delivered by sales representatives to customers who were asked to do the following: Ensure the blood pump is securely locked into the motor, following the IFU. If you are unable to fully rotate and lock a blood pump into a motor, exchange the pump for a new one, and return the original pump to Abbott for a full refund or credit, please contact your Abbott Representative or Abbott Customer Service at 1-800-456-1477. Continue to follow the IFU, which can be accessed on firm website: https://manuals.eifu.abbott/en/index.html, and also follow the Pump Setup, Appendix A, in this notice, which states: The following pictures on Figure 1 clarify the IFU. After matching the grooves on the periphery of the Pump with the fittings on the motor receptacle, proceed with the following: 1. Ensuring that the pump remains flat/level with the motor/ to the pump, Rotate the pump counterclockwise until the matching groove on the pump is located in front of the locking screw. 2. Turn the locking screw until it is completely seated into the groove and the blood pump is secured in place. 3. Do not lock screw if groove is not located in front of the locking screw. 4. Always rely on visual confirmation that the pump is correctly locked in the motor, even if the "pump not inserted" alarm is not present. Communicate this information with those in your facility to whom it is relevant. Firm asks customers to notify all involved parties that support patients with affected devices. Complete and return the Acknowledgment and Receipt Form via email to CentriMagNotices@abbott.com Firm has implemented an in-process manufacturing step to confirm the pumps can be fitted into the motor while continuing with the implementation of corrective actions to help ensure that new blood pumps will lock into the motor.

Quantity

8399

Distribution

Worldwide - US Nationwide distribution including in the states of MN, PA, OK, FL, CA, OR, IL, NY, DE, GA, NJ, NC, WI, OH, AZ, AR, TX, TN, MO, MA, MT, KY, NE, WV, VA, ME, ND, AL, CO, DC, MS, IN, MI, CT, SC, WA, NM, MD, HI, ID, IA, LA, UT, RI, NV and the countries of Algeria, Australia, Austria, Bahrain, CANADA, Cayman Islands, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Hong Kong, Italy, Jordan, Kuwait, Lithuania, Macedonia, Malaysia, Mexico, Netherlands, Oman, Peru, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom.

Lot, serial or model codes

UDI-DI: 07640135140627, 07640135140603, 05415067036414 IFU: Part(Name) Revision: For US: 1. ARTEN600254920 (IFU CentriMag Blood Pump ABT) Rev C 2. ARTEN600254958 (IFU PediMag Blood Pump US ABT) Rev C 3. ARTEN100174794 (CentriMag Adult Pre-connected Pack IFU, US) Rev B 4. ARTEN600230157 (IFU CentriMag Blood Pump ECMO US) Rev D FOR OUS: ARTEN600254935 (IFU CentriMag Blood Pump CAN ABT) Rev C ARTEN600254936 (IFU PediVas Blood Pump Canada ABT) Rev C ARTEN600332205 (IFU CMag VAS-ECMO Pump OUS) Rev A ARTEN600332207 (IFU PVAS VAS-ECMO Pump OUS) Rev A REF 201-20003, 104318, 201-51006, 201-51007, 201-90001 201-90001T don't have associated un-expired batches/serial numbers. REF/Batch(Serial): 102953/10007334, 10007335, 10007336, 10012012, 10012013, 10012014, 10012015, 10012016, 10036179, 10036180, 10036181, 10037990, 10037992, 10037993, 10037995, 10037996, 10046028, 10046029, 10046030, 10046031, 10046032, 10046033, 10058754, 10058755, 10058756, 10061673, 10061675, 10061676, 10061677, 10065946, 10065947, 10065954, 10065955, 10065956, 10071358, 10071359, 10071361, 10073780, 10073781, 10073783, 10082053, 10082055, 10103208, 10103209, 10106345, 10106346, 10106347, 10106348, 10120074, 10120075, 10120076, 10120077, 10122157, 10122158, 10122159, 10125562, 10125563, 10125564, 10125565, 10138336, 10138337, 10138338, 10138339, 10145124, 10145125, 10145126, 10145127, 10164040, 10164041, 10164044, 10168193, 10168194, 10168195, 10168196, 10168197, 10168199, 10168200, 10168201, 10168202, 10168203, 10173214, 10173215, 10206751, 10206752, 10206754, 10211194, 10211195, 10211196, 10211198, 10211199, 10214967, 10214968, 10214969, 10214970, 10214971, 10235009, 10235014, 10235019, 10235024, 10245539, 10245540, 10245541, 10245542, 10245543, 10256365, 10256366, 10289217, 10289218, 10291590, 10291591, 10301036, 10301037, 10301038, 10301039, 10301040, 10301041, 10301042, 10301043, 10301044, 10303473, 10303476, 10303477, 10303478, 10325561, 10341677, 10342238 10343635, 10343636, 10343637, 10343638, 10343639, 10343640, 10351700, 10351701, 10351702, 10351703, 10351704, 10351707, 10359524, 10359525, 10359526, 10359527, 10359528, 10359529, 10359530, 10359531, 10359532, 10371222, 10371223, 10371224, 10371225, 10371226, 10373595, 10373596, 10373597, 10373598, 10373599, 10391563, 10391564, 10391565, 10391566, 10398007, 10398008, 10398009, 10398010, 10398011, 10399853, 10399854, 10399855, 10399856, 10399857, 10399858, 10399859, 10399860, 10399861, 10399862, 10399866, 10399867, 10410026, 10410027, 10410028, 10410197, 10410198, 10410199, 10411641, 10411642, 10414322, 10414323, 10414324, 10414325, 10414326, 10416065, 10416066, 10416067, 10418871, 10419212, 10424524, 10428901, 10428902, 10428904, 10428905, 10428906, 10456505, 10456506, 10456507, 10456508, 10456509, 10457499, 10457500, 10457502, 10464083, 10464085, 10464086, 10464092, 10498116, 10498117, 10498118, 10517215, 10518978, 10518979, 10518980, 10518981, 10518982, 10528585, 10528587, 10528588, 10530704, 10530705, 10530706, 10535290, 10535294, 10535297, 10535299, 10535300, 10535302, 10541032, 10541033, 10541034, 10541035, 10543873, 10543874, 10550324, 10550325, 10550326, 10550328, 10550329, 10560628, 10560629, 10560630, 10567320, 10567321, 10567322, 10567323, 10571084, 10571085, 10571086, 10571087, 10571088, 10571090, 10588824, 10588825, 10588826, 10591390, 10591391, 10591392, 10591393, 10602157, 10602160, 10602161, 10602162, 10602163, 10602164, 10623578, 10623579, 10623581, 10623582, 10623583, 10632619, 10632625, 10632630, 10639955, 10639956, 10639957, 10639959, 10639960, 10646446, 10646447, 10646449, 10646450, 10646451, 10646452, 10650250, 10650251, 10652470, 10652471, 10652472, 10652473, 10652474, 10652475, 10652477, 10652479, 10659763, 10659764, 10663359, 10663361, 10663363, 10670118, 10670122, 10670123, 10670124, 10671920, 10671921, 10671922, 10671923, 10671925, 10680535, 10680536, 10680538, 10680539, 10680540, 10683369, 10683370, 10683371, 10683372, 10688155, 10688156, 10688157, 10688158, 10688159, 10688160, 10694256, 10694258, 10694260, 10694262, 10694264, 10694266, 10694268, 10694270, 10694272, 10694273, 10694274, 10694275, 10694296, 10712284, 10712285, 10716549, 10716551, 10716552, 10716553, 10716554, 10727906, 10727907, 10727908, 10727909, 10727910, 10727911, 10727912, 10748553, 10748554, 10748556, 10748557, 10771409, 10771411, 10771412, 10773388, 10773389, 10773390, 10773391, 10773392, 10773393, 10773394, 10776304, 10776308, 10776310, 10776316, 10776317, 10783737, 10783738, 10783739, 10783740, 10783741, 10788706, 10788707, 10788708, 10788709, 10788710, 10788711, 10816789, 10816790, 10816791, 10817064, 10817065, 10821308, 10821309, 10821310, 10828333, 10828334, 10828335, 10828336, 10828337, 10832541, 10832543, 10832544, 10832545, 10832547, 10832548, 10834958, 10834959, 10834960, 10834961, 10834962, 10834963, 10834964, 10834965, 10834966, 10834967, 10834968, 10834969, 10875109, 10875110, 10875111, 10875112, 10875113, 10877738, 10877739, 10877740, 10877742, 10877743, 10877744, 10879671, 10879672, 10879673, 10879674, 10879676, 10879677, 10879678, 10879679, 10879680, 10879682, 10879683, 10879684, 10879685, 10879686, 10879687, 10896069, 10896070, 10896071, 10911663, 10911665, 10911667, 10911669, 10911671, 10911675, 10941952, 10941953, 10941954, 10941955, 10941956, 10947110, 10947111, 10947112, 10947113, 10947114, 10947603, 10947604, 10947605, 10947607, 10947608, 10952744, 10952746, 10952747, 10952749, 10952750, 10956143, 10956144, 10956145, 10960853, 10985404, 10985408, 10985409, 10985410, 10989308, 10989309, 10989311, 11013097, 11013099, 11013100, 11013101, 9103442, 9143416, 9143417, 9174168, 9237175, 9237176, 9237177; 201-90010/10012019, 10012020, 10012021, 10012022, 10012023, 10012024, 10012025, 10012026, 10026482, 10026483, 10026484, 10026485, 10026486, 10026487, 10026488, 10026489, 10061666, 10061668, 10061669, 10061671, 10075586, 10075587, 10075588, 10082037, 10082039, 10082040, 10082041, 10106341, 10106342, 10106343, 10106344, 10114497, 10114499, 10114500, 10118096, 10118097, 10118098, 10118099, 10118100, 10118101, 10118102, 10118103, 10122160, 10122161, 10122162, 10122163, 10157219, 10157220, 10157221, 10184547, 10184548, 10184549, 10184551, 10184553, 10184554, 10184555, 10190508, 10190509, 10194010, 10214972, 10214973, 10234422, 10234423, 10234424, 10235052, 10250573, 10250574, 10250576, 10250577, 10256367, 10256368, 10256369, 10256370, 10256371, 10256372, 10256373, 10261919, 10261920, 10261921, 10261923, 10279769, 10333758, 10333759, 10333760, 10339372, 10339373, 10339374, 10343663, 10343664, 10343665, 10351697, 10351698, 10351699, 10379489, 10379490, 10379491, 10383826, 10383827, 10383828, 10383829, 10391724, 10391725, 10391726, 10391727, 10391730, 10391732, 10391733, 10413131, 10413132, 10413133, 10413135, 10413561, 10413565, 10413566, 10418562, 10462022, 10462023, 10462024, 10470479, 10470521, 10470524, 10472542, 10472550, 10474373, 10474374, 10474376, 10474377, 10498175, 10498176, 10501172, 10501173, 10503762, 10528582, 10543891, 10543892, 10552629, 10552630, 10552631, 10560591, 10560620, 10560621, 10560622, 10560623, 10560624, 10567338, 10567342, 10567343, 10567344, 10571082, 10571083, 10586726, 10586727, 10586728, 10591394, 10591395, 10591396, 10598036, 10598037, 10598038, 10598039, 10598040, 10602152, 10602153, 10602154, 10602155, 10602156, 10619564, 10619565, 10619566, 10619567, 10619568, 10621605, 10621606, 10621607, 10621608, 10621611, 10632450, 10632451, 10636575, 10640045, 10640050, 10640051, 10650671, 10650677, 10650680, 10650681, 10659755, 10659756, 10659757, 10659758, 10659759, 10659760, 10659761, 10663352, 10663353, 10663354, 10727899, 10727900, 10727901, 10727902, 10727903, 10727904, 10727905, 10735527, 10735528, 10735530, 10738501, 10739056, 10739065, 10739066, 10739067, 10739068, 10739069, 10739070, 10739071, 10739072, 10748571, 10748573, 10748574, 10778162, 10778164, 10778165, 10797739, 10797742, 10797746, 10815359, 10815362, 10815363, 10815364, 10816785, 10816786, 10816787, 10821305, 10821306, 10821307, 10828329, 10828330, 10828331, 10828332, 10828529, 10832540, 10835410, 10847295, 10847297, 10847298, 10847299, 10847300, 10847301, 10847302, 10847303, 10858660, 10858661, 10859392, 10859400, 10859403, 10859406, 10859407, 10872106, 10872108, 10872109, 10872111, 10872113, 10875119, 10875123, 10875126, 10875128, 10877758, 10877759, 10877760, 10893762, 10893763, 10893764, 10893765, 10893768, 10893769, 11001344, 11001345, 11001347, 9088894, 9088895, 9088897, 9088898, 9088899, 9088900, 9188312, 9230175, 9239396, 9239397, 9239398, 9239879, 9239880, 9239883, 9251990, 9251991, 9251992, 9251993; 201-90016/10104959, 10109004, 10148485, 10148517, 10195550, 10395893, 10477785, 10528583, 10560573, 10579395, 10579396, 10630119, 10665672, 10916780, 10916781, 10969131, 9163847, 9239394; CMAEK00/CMAEK00(20236575, 20236576, 20236577, 20236578, 20236579, 20236580, 20236581, 20236582, 20236583, 20236584, 20236585, 20236586, 20236587, 20236588, 20236589, 20236590, 20236591, 20236592), 10438711(20236593, 20236594, 20236595, 20236596, 20236597, 20236598, 20236599, 20236600, 20236601, 20236602, 20236603, 20236604, 20236605, 20236607, 20236608, 20236609, 20236610), 10451609(20236611, 20236612, 20236613, 20236614, 20236615, 20236616, 20236617, 20236619, 20236620, 20236621, 20236622, 20236623, 20236624, 20236625, 20236626, 20236627, 20236628), 10451610(20256947, 20256948, 20256949, 20256950, 20256951, 20256952, 20256953, 20256955, 20256956, 20256957, 20256958, 20256959, 20256960, 20256961, 20256962, 20256963, 20256964), 10451615(20256965, 20256966, 20256967, 20256968, 20256969, 20256970, 20256971, 20256972, 20256973, 20256974, 20256975, 20256976, 20256977, 20256978, 20256979, 20256980, 20256982), 10451617(20256983, 20256984, 20256985, 20256986, 20256987, 20256988, 20256989, 20256990, 20256991, 20256992, 20256993, 20256994, 20256995, 20256996, 20256997, 20256998, 20256999, 20257000), 10463759(20278309, 20278310, 20278311, 20278312, 20278313, 20278314, 20278315, 20278316, 20278317, 20278318, 20278319, 20278320, 20278321, 20278322, 20278323, 20278324, 20278325, 20278326), 10463760(20278327, 20278328, 20278329, 20278330, 20278331, 20278332, 20278333, 20278334, 20278335, 20278336, 20278337, 20278338, 20278339, 20278340, 20278341, 20278342, 20278343, 20278344), 10552471(20278363 20278365, 20278366, 20278367, 20278368, 20278369, 20278370, 20278371, 20278372, 20278373, 20278374, 20278375, 20278376, 20278377, 20278378, 20278379, 20278380), 10552472(20278345, 20278346, 20278348, 20278349, 20278350, 20278351, 20278352, 20278353, 20278354, 20278355, 20278356, 20278357, 20278358, 20278359, 20278360, 20278361, 20278362), 10552475(20278381, 20278382, 20278383, 20278384, 20278385, 20278386, 20278387, 20278388, 20278389, 20278390, 20278391, 20278392, 20278394, 20278395, 20278396, 20278397, 20278398), 10552484(20284132, 20284133, 20284134, 20284136, 20284137, 20284138, 20284139, 20284141, 20284142, 20284143, 20284144, 20284145, 20284146, 20284147, 20284148, 20284149), 10552486(20284114, 20284115, 20284116, 20284117, 20284118, 20284119, 20284120, 20284121, 20284122, 20284123, 20284124, 20284125, 20284126, 20284127, 20284128, 20284129, 20284130, 20284131), 10552487(20342251, 20342252, 20342253, 20342254, 20342255, 20342256, 20342257, 20342258, 20342259, 20342260, 20342261, 20342262, 20342263, 20342264, 20342265, 20342266, 20342267, 20342268), 10574868(20302808, 20302810, 20302811, 20302812, 20302813, 20302814, 20302815, 20302816, 20302817, 20302818, 20302819, 20302820, 20302821, 20302822, 20302823, 20302824, 20302825), 10574869(20302714, 20302715, 20302716, 20302717, 20302718, 20302719, 20302720, 20302721, 20302722, 20302723, 20302724, 20302725, 20302726, 20302727, 20302728, 20302729, 20302730, 20302731), 10574872(20302732, 20302733, 20302734, 20302735, 20302736, 20302737, 20302738, 20302739, 20302740, 20302741, 20302742, 20302743, 20302744, 20302745, 20302746, 20302747, 20302748, 20302749), 10574873(20302750, 20302751, 20302752, 20302753, 20302754, 20302755, 20302756, 20302757, 20302758, 20302759, 20302760, 20302761, 20302762, 20302763, 20302764, 20302765, 20302766), 10574875(20302790, 20302791, 20302792, 20302793, 20302794, 20302795, 20302796, 20302797, 20302798, 20302799, 20302800, 20302801, 20302802, 20302804, 20302805, 20302806, 20302807), 10574876(20302768, 20302770, 20302771, 20302772, 20302773, 20302774, 20302775, 20302776, 20302777, 20302778, 20302779, 20302780, 20302781, 20302783, 20302784, 20302785), 10623548(20356887, 20356888, 20356889, 20356890, 20356891, 20356892, 20356893, 20356894, 20356895, 20356896, 20356897, 20356898, 20356899, 20356900, 20356901, 20356902, 20356903, 20356904), 10623549(20356959, 20356960, 20356961, 20356962, 20356963, 20356964, 20356965, 20356966, 20356967, 20356969, 20356971, 20356973, 20356974, 20356975), 10623550(20361617, 20361618, 20361619, 20361620, 20361621, 20361622, 20361623, 20361624, 20361625, 20361626, 20361627, 20361628, 20361629, 20361630, 20361631, 20361632, 20361633, 20361634), 10623551(20361635, 20361636, 20361637, 20361638, 20361639, 20361640, 20361641, 20361642, 20361643, 20361644, 20361645, 20361646, 20361647, 20361648, 20361649, 20361650, 20361651, 20361652), 10623552(20356941, 20356942, 20356943, 20356944, 20356945, 20356946, 20356947, 20356948, 20356949, 20356950, 20356951, 20356952, 20356953, 20356954, 20356955, 20356956, 20356957), 10623553(20356923, 20356924, 20356925, 20356926, 20356927, 20356928, 20356929, 20356930, 20356931, 20356932, 20356933, 20356934, 20356935, 20356936, 20356937, 20356938, 20356940), 10623554(20361582, 20361583, 20361584, 20361585, 20361586, 20361587, 20361588, 20361589, 20361590, 20361591, 20361592, 20361593, 20361594, 20361595, 20361596, 20361597, 20361598), 10649991(20356905, 20356906, 20356907, 20356908, 20356909, 20356910, 20356911, 20356912, 20356913, 20356914, 20356915, 20356916, 20356917, 20356918, 20356919, 20356920, 20356922), 10649992(20361563, 20361564, 20361565, 20361566, 20361567, 20361569, 20361570, 20361571, 20361572, 20361573, 20361574, 20361575, 20361576, 20361577, 20361578, 20361579, 20361580), 10649993(20361599, 20361600, 20361601, 20361602, 20361603, 20361604, 20361605, 20361607, 20361611, 20361612, 20361613, 20361614), 10649994(20375956, 20375957, 20375958, 20375959, 20375960, 20375961, 20375962, 20375963, 20375964, 20375965, 20375966, 20375968, 20375970, 20375971, 20375972, 20375973), 10649995(20375974, 20375975, 20375976, 20375977, 20375978, 20375980, 20375981, 20375982, 20375983, 20375984, 20375985, 20375986, 20375987, 20375988, 20375989, 20375990, 20375991), 10671740(20409885, 20409886, 20409887, 20409888, 20409889, 20409890, 20409891, 20409893, 20409894, 20409895, 20409896, 20409897, 20409898, 20409899, 20409900, 20409901, 20409902), 10671741(20409903, 20409904, 20409905, 20409906, 20409907, 20409908, 20409910, 20409911, 20409912, 20409913, 20409914, 20409915, 20409916, 20409918, 20409919, 20409920), 10671743(20409921, 20409922, 20409923, 20409924, 20409925, 20409926, 20409928, 20409929, 20409930, 20409931, 20409932, 20409933, 20409934, 20409935, 20409936, 20409938), 10671745(20409939, 20409940, 20409941, 20409942, 20409943, 20409944, 20409945, 20409946, 20409947, 20409948, 20409949, 20409950, 20409952, 20409953, 20409954, 20409955, 20409956), 10715960(20409957, 20409958, 20409959, 20409960, 20409961, 20409962, 20409963, 20409964, 20409965, 20409966, 20409967, 20409968, 20409970, 20409971, 20409972, 20409973, 20409974), 10715961(20412892, 20412893, 20412894, 20412895, 20412896, 20412897, 20412898, 20412899, 20412900, 20412901, 20412902, 20412903, 20412904, 20412905, 20412906, 20412907, 20412908, 20412909), 10715962(20412910, 20412911, 20412912, 20412913, 20412914, 20412915, 20412916, 20412917, 20412918, 20412919, 20412920, 20412921, 20412922, 20412923, 20412924, 20412925, 20412926, 20412927), 10779655(20412928, 20412929, 20412930, 20412931, 20412932, 20412933, 20412934, 20412935, 20412936, 20412937, 20412938, 20412939, 20412940, 20412941, 20412942, 20412943, 20412944, 20412945), 10779656(20412946, 20412947, 20412948, 20412950, 20412952, 20412953, 20412954, 20412956, 20412957, 20412958, 20412959, 20412960, 20412961, 20412962, 20412963), 10794262(20430144, 20430145, 20430146, 20430147, 20430148, 20430149, 20430150, 20430151, 20430152, 20430153, 20430154, 20430155, 20430156, 20430157, 20430158, 20430159, 20430161), 10794264(20430180, 20430182, 20430183, 20430184, 20430185, 20430186, 20430187, 20430188, 20430189, 20430190, 20430191, 20430192, 20430193, 20430194, 20430195, 20430196, 20430197), 10794266(20430198, 20430200, 20430201, 20430202, 20430203, 20430204, 20430205, 20430206, 20430207, 20430208, 20430209, 20430210, 20430211, 20430212, 20430213, 20430214, 20430215), 10794268(,20430162, 20430163, 20430164, 20430165, 20430166, 20430168, 20430169, 20430170, 20430171, 20430172, 20430173, 20430174, 20430175, 20430176, 20430177, 20430179), 10794269(20432844, 20432845, 20432846, 20432847, 20432848, 20432849, 20432850, 20432851, 20432853, 20432854, 20432855, 20432856, 20432857, 20432858, 20432859, 20432860, 20432861), 10805521(20430222, 20430223, 20430224, 20430225, 20430226, 20430227, 20430228, 20430229, 20430230, 20430231, 20430232, 20430233, 20430234, 20430235, 20430236, 20430237, 20430238, 20430239), 10805522(20430244, 20430245, 20430246, 20430247, 20430248, 20430249, 20430250, 20430251, 20430252, 20430253, 20430254, 20430255, 20430256, 20430257, 20430258, 20430259, 20430260, 20430261), 10805523(20430262, 20430263, 20430264, 20430265, 20430266, 20430267, 20430268, 20430269, 20430270, 20430271, 20430272, 20430273, 20430274, 20430275, 20430276, 20430277, 20430278, 20430279), 10805524(20457844, 20457845, 20457846, 20457847, 20457848, 20457849, 20457850, 20457851, 20457852, 20457853, 20457854, 20457855, 20457856, 20457857, 20457858, 20457859, 20457860), 10805525(20457862, 20457864, 20457865, 20457867, 20457868, 20457869, 20457870, 20457871, 20457872, 20457873, 20457874, 20457875, 20457876, 20457877, 20457878, 20457879), 10834379(20457880, 20457881, 20457882, 20457883, 20457884, 20457885, 20457886, 20457887, 20457888, 20457889, 20457890, 20457891, 20457892, 20457893, 20457894, 20457895, 20457896, 20457897), 10834385(20481824, 20481826, 20481829, 20481832, 20481834, 20481835, 20481839, 20481841), 10834397(20481807, 20481809, 20481812, 20481814, 20481815, 20481821, 20481822, 20481823); CMAEK01/10485765(20284196, 20284197, 20284198, 20284199, 20284200, 20284201, 20284202, 20284203, 20284204, 20284205, 20284206, 20284207, 20284208, 20284209, 20284210, 20284211, 20284212, 20284213), 10485769(20284214, 20284216, 20284217, 20284218, 20284219, 20284220, 20284221, 20284222, 20284223, 20284224, 20284225, 20284226, 20284227, 20284228, 20284229, 20284230, 20284231), 10506836(20261873, 20261874, 20261875, 20261876, 20261877, 20261878, 20261879, 20261880, 20261881, 20261882, 20261883, 20261884, 20261885, 20261886, 20261887, 20261889, 20261890), 10506837(20261891, 20261892, 20261893, 20261894, 20261895, 20261896, 20261897, 20261898, 20261899, 20261900, 20261901, 20261902, 20261903, 20261904, 20261905, 20261906, 20261907, 20261908), 10506839(20261945, 20261946, 20261947, 20261949, 20261950, 20261951, 20261952, 20261953, 20261955, 20261957, 20261958, 20261959, 20261962), 10506840(20261909, 20261911, 20261912, 20261913, 20261914, 20261918, 20261919, 20261920, 20261921, 20261922, 20261924, 20261925, 20261926), 10506841(20261927, 20261928, 20261929, 20261930, 20261931, 20261932, 20261933, 20261934, 20261935, 20261936, 20261937, 20261938, 20261940, 20261943), 10547650(20284269, 20284277), 10547655(20284294, 20284296, 20284297, 20284298, 20284299, 20284300, 20284302, 20284303, 20284304, 20284306, 20284308, 20284310, 20284311), 10605980(20361662, 20361663, 20361664, 20361665, 20361668, 20361669, 20361670), 10605982(20375884, 20375885, 20375887, 20375888, 20375889, 20375890, 20375891, 20375892, 20375895, 20375896, 20375898, 20375899, 20375900, 20375901), 10605987(20375938, 20375939, 20375940, 20375941, 20375942, 20375943, 20375944, 20375945, 20375946, 20375947, 20375948, 20375949, 20375950, 20375951, 20375952, 20375953, 20375954), 10605988(20375902, 20375903, 20375904, 20375905, 20375906, 20375907, 20375908, 20375909, 20375910, 20375911, 20375912, 20375913, 20375914, 20375915, 20375917, 20375918, 20375919), 10605989(20375921, 20375922, 20375924, 20375925, 20375926, 20375927, 20375929, 20375930, 20375931, 20375932, 20375933, 20375934, 20375935, 20375936, 20375937), 10671735(20422760, 20422761, 20422762, 20422763, 20422764, 20422765, 20422766, 20422767, 20422768, 20422769, 20422770, 20422771, 20422772, 20422773, 20422774, 20422775, 20422776), 10671737(20422777, 20422778, 20422779, 20422780, 20422781, 20422782, 20422783, 20422784, 20422785, 20422786, 20422787, 20422789, 20422790, 20422791, 20422792, 20422794), 10671738(20422795, 20422796, 20422797, 20422798, 20422799, 20422800, 20422801, 20422802, 20422803, 20422805, 20422807, 20422808, 20422809, 20422810, 20422811, 20422812), 10715950(20422705, 20422706, 20422707, 20422708, 20422709, 20422710, 20422711, 20422713, 20422715, 20422716, 20422717, 20422718, 20422719, 20422720, 20422721, 20422722), 10715951(20422725, 20422726, 20422728, 20422733, 20422734, 20422735, 20422736, 20422739, 20422740), 10715951(20422725, 20422726, 20422728, 20422733, 20422734, 20422735, 20422736, 20422739, 20422740), 10715952(20422742, 20422743, 20422745, 20422746, 20422747, 20422748, 20422754, 20422755, 20422756, 20422757, 20422758), 10715956(20422814, 20422816, 20422818, 20422819, 20422821, 20422822, 20422823, 20422824, 20422825, 20422826), 10715957(20443495, 20443496, 20443497, 20443498, 20443499, 20443500, 20443501, 20443502, 20443503, 20443504, 20443505, 20443506, 20443507, 20443508, 20443512), 10715958(20443513, 20443514, 20443516, 20443517, 20443518, 20443522, 20443524, 20443525, 20443527, 20443528, 20443530), 10757855(20443533, 20443535, 20443536, 20443537, 20443538, 20443539, 20443540, 20443545, 20443546, 20443547, 20443548), 10757856(20443549, 20443551, 20443552, 20443553, 20443555, 20443556, 20443557, 20443558, 20443560, 20443562, 20443563, 20443564, 20443565, 20443566), 10757858(20446755, 20446761), 10757859(20446726, 20446727, 20446728, 20446729, 20446730, 20446731, 20446732, 20446733, 20446734, 20446735, 20446736, 20446737, 20446738, 20446739, 20446740, 20446741, 20446742, 20446743), 10794274(20457826, 20457827, 20457828, 20457829, 20457830, 20457831, 20457835), 10805518(20481842, 20481846, 20481849, 20481850, 20481851, 20481852, 20481853, 20481854, 20481856, 20481857), 10805519(20481869, 20481871, 20481874, 20481876), 10844705(20513099, 20513100, 20513102, 20513104, 20513105, 20513107, 20513110, 20513111, 20513115), 10844706(20513118, 20513122, 20513123, 20513124, 20513131, 20513133), 10944546(20570873, 20570874, 20570881, 20570882, 20570883, 20570884, 20570885, 20570886, 20570887, 20570888)

510(k) numbers

["K222038"]

PMA numbers

not on file

Product code

QNR

Firm FEI

2916596

Firm city

Pleasanton

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy